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文档大小：164.1 MB
文档个数：168个文档
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收录时间：2025-04-03
最近下载：2025-04-03
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文档列表

0114_2/m3/32-body-data/32a-app/32a1-fac-equip/common/gd07-bulkmanufacturing-tt-drawings.pdf 27.6 MB
0114_2/m3/32-body-data/32a-app/32a1-fac-equip/common/sa03-adsorption-drawings.pdf 27.6 MB
0114_2/m3/32-body-data/32a-app/32a1-fac-equip/common/gd07-bulkmanufacturing-dt-drawings.pdf 22.3 MB
0114_2/m1/eu/12-form/common/common-form-eaf.pdf 4.9 MB
0114_2/m1/eu/12-form/sk/sk-form-eaf.pdf 4.4 MB
0114_2/m1/eu/12-form/common/common-form-annex-chmpscientificadvice.pdf 3.2 MB
0114_2/m1/eu/12-form/no/no-form-eaf.pdf 2.9 MB
0114_2/m1/eu/12-form/common/common-form-annex-manufauthorisationgskgd.pdf 2.4 MB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s2-manuf/process-validation-d.pdf 2.1 MB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s2-manuf/process-validation-ppqt.pdf 1.8 MB
0114_2/m1/eu/12-form/pl/pl-form-annex-establishmentmah.pdf 1.6 MB
0114_2/m1/eu/12-form/common/common-form-annex-scopebackground-generalpart.pdf 1.4 MB
0114_2/m1/eu/12-form/se/se-form-annex-powerofattorney.pdf 1.2 MB
0114_2/m1/eu/12-form/cz/cz-form-eaf.pdf 1.1 MB
0114_2/m1/eu/12-form/common/common-form-annex-scopebackground-parta.pdf 1.0 MB
0114_2/m1/eu/12-form/el/el-form-eaf.pdf 1.0 MB
0114_2/m1/eu/12-form/common/common-form-annex-scopebackground-partc.pdf 990.2 kB
0114_2/m3/32-body-data/32p-drug-prod/pre-filled-syringe/32p3-manuf/process-validation-ppqdtcc.pdf 968.2 kB
0114_2/m1/eu/12-form/el/el-form-annex-proofofpayment.pdf 949.2 kB
0114_2/m1/eu/12-form/fr/fr-form-annex-proofofpayment.pdf 945.1 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s7-stab/stability-data-longtermd.pdf 889.4 kB
0114_2/m1/eu/12-form/common/common-form-annex-gmpcertificategskgd.pdf 860.8 kB
0114_2/m1/eu/12-form/common/common-form-annex-2-scopebackground.pdf 831.4 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s7-stab/stability-data-longtermt.pdf 825.4 kB
0114_2/m1/eu/additional-data/pl/pl-additionaldata-powerofattorney-agreement.pdf 816.1 kB
0114_2/m3/32-body-data/32a-app/32a1-fac-equip/common/gd07-bulkmanufacturing-dt.pdf 794.2 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s7-stab/stability-data-acceleratedd.pdf 790.8 kB
0114_2/m1/eu/12-form/common/common-form-annex-scopebackground-partb.pdf 775.6 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s2-manuf/process-validation-uflifetimed.pdf 755.2 kB
0114_2/m1/eu/10-cover/common/common-tracking.pdf 745.5 kB
0114_2/m2/23-qos/drug-substance-manufactured.pdf 694.6 kB
0114_2/m1/eu/12-form/common/common-form-annex-presentandproposed.pdf 692.1 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s7-stab/stability-data-acceleratedt.pdf 684.9 kB
0114_2/m1/eu/12-form/common/common-form-annex-annexb.pdf 680.2 kB
0114_2/m1/eu/10-cover/common/common-cover-annex-acceptabilityofws.pdf 672.1 kB
0114_2/m3/32-body-data/32a-app/32a1-fac-equip/common/gd07-bulkmanufacturing-tt.pdf 654.6 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s2-manuf/process-validation-uflifetimet.pdf 636.9 kB
0114_2/m1/eu/12-form/pl/pl-form-eaf.pdf 615.3 kB
0114_2/m1/eu/12-form/common/common-form-annex-scopebackground-partd.pdf 605.6 kB
0114_2/m1/eu/10-cover/ie/ie-cover.pdf 598.8 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s2-manuf/process-validation-uflifetimecrudet.pdf 596.9 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s2-manuf/process-validation-uflifetimecruded.pdf 595.9 kB
0114_2/m1/eu/12-form/common/common-form-annex-3-scopebackground.pdf 593.4 kB
0114_2/m2/23-qos/drug-substance-controlofdrugsubstanced.pdf 576.2 kB
0114_2/m2/23-qos/drug-product-manufacturedtcc.pdf 573.3 kB
0114_2/m3/32-body-data/32p-drug-prod/pre-filled-syringe/32p7-cont-closure-sys/container-closure-system-dtcc.pdf 572.0 kB
0114_2/m2/23-qos/drug-substance-manufacturet.pdf 570.8 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s6-cont-closure-sys/container-closure-system-extractablesplasticbagsdt.pdf 569.9 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s6-cont-closure-sys/container-closure-system-extractablesplasticbagsdt.pdf 569.9 kB
0114_2/m2/23-qos/drug-substance-controlofdrugsubstancet.pdf 569.7 kB
0114_2/m2/23-qos/drug-substance-stabilityd.pdf 550.2 kB
0114_2/m2/23-qos/drug-substance-stabilityt.pdf 535.1 kB
0114_2/m3/32-body-data/32a-app/32a1-fac-equip/common/sa03-adsorption.pdf 532.8 kB
0114_2/m1/eu/10-cover/common/common-cover.pdf 530.6 kB
0114_2/m3/32-body-data/32p-drug-prod/pre-filled-syringe/32p3-manuf/manuf-process-and-controls-dtcc.pdf 508.6 kB
0114_2/m1/eu/12-form/common/common-form-annex-5-scopebackground.pdf 487.3 kB
0114_2/m1/eu/12-form/common/common-form-annex-4-scopebackground.pdf 481.2 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s4-contr-drug-sub/32s45-justif-spec/justification-of-specification-overviewd.pdf 480.1 kB
0114_2/m3/32-body-data/32p-drug-prod/pre-filled-syringe/32p3-manuf/control-critical-steps-stabilitydtcc.pdf 479.0 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s2-manuf/control-critical-steps-microbpurityt.pdf 467.5 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s2-manuf/control-critical-steps-fermentationd.pdf 461.5 kB
0114_2/m3/32-body-data/32a-app/32a1-fac-equip/common/gd07-containmenttt.pdf 455.7 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s4-contr-drug-sub/32s45-justif-spec/justification-of-specification-overviewt.pdf 454.0 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s2-manuf/control-critical-steps-turbidityd.pdf 437.4 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s6-cont-closure-sys/container-closure-system-suitabilityplasticbagsdt.pdf 437.2 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s6-cont-closure-sys/container-closure-system-suitabilityplasticbagsdt.pdf 437.2 kB
0114_2/m3/32-body-data/32a-app/32a1-fac-equip/common/sa03-containment.pdf 436.4 kB
0114_2/m3/32-body-data/32p-drug-prod/pre-filled-syringe/32p3-manuf/control-critical-steps-qctestingdtcc.pdf 418.6 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s2-manuf/manuf-process-development-manufacturingprocessdevelopmentd.pdf 416.5 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s2-manuf/control-critical-steps-fermentationt.pdf 412.0 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s2-manuf/control-critical-steps-stabilitycrudet.pdf 411.2 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s2-manuf/control-critical-steps-microbpurityd.pdf 408.4 kB
0114_2/m3/32-body-data/32p-drug-prod/pre-filled-syringe/32p3-manuf/control-critical-steps-batchanalysisdtcc.pdf 408.0 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s2-manuf/control-critical-steps-stabilitycruded.pdf 407.5 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s2-manuf/control-critical-steps-detoxificationandultrafiltnt.pdf 406.4 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s2-manuf/manuf-process-development-manufacturingprocessdevelopmentt.pdf 406.0 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s7-stab/stability-summary-d.pdf 405.9 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s7-stab/stability-summary-t.pdf 405.0 kB
0114_2/m3/32-body-data/32a-app/32a1-fac-equip/common/gd07-containmentdt.pdf 402.8 kB
0114_2/m1/eu/10-cover/pl/pl-cover.pdf 400.0 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s2-manuf/control-critical-steps-detoxificationandultrafiltrationd.pdf 390.1 kB
0114_2/m1/eu/additional-data/pl/pl-additionaldata-powerofattorney.pdf 387.5 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s2-manuf/manuf-process-and-controls-fermentationt.pdf 382.9 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s2-manuf/manuf-process-and-controls-purificationd.pdf 370.7 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s2-manuf/manuf-process-and-controls-overviewd.pdf 367.6 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s2-manuf/manuf-process-and-controls-fermentationd.pdf 365.8 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s2-manuf/control-critical-steps-purificationd.pdf 361.5 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s2-manuf/control-critical-steps-purificationt.pdf 359.3 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s4-contr-drug-sub/32s42-analyt-proc/analytical-procedure-overviewd.pdf 353.4 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s2-manuf/manuf-process-and-controls-purificationt.pdf 351.4 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s2-manuf/control-of-materials-materialsolutiont.pdf 349.8 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s4-contr-drug-sub/32s44-batch-analys/batch-analyses-overviewd.pdf 349.3 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s4-contr-drug-sub/32s44-batch-analys/batch-analyses-overviewt.pdf 348.0 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s2-manuf/manuf-process-and-controls-overviewt.pdf 346.8 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s2-manuf/manuf-process-and-controls-detoxificationandultrafiltnd.pdf 338.4 kB
0114_2/m3/32-body-data/32a-app/32a1-fac-equip/common/facilities-and-equipment-flowchartfacilities.pdf 336.9 kB
0114_2/m1/eu/10-cover/si/si-cover.pdf 335.6 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s4-contr-drug-sub/32s42-analyt-proc/analytical-procedure-overviewt.pdf 335.3 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s6-cont-closure-sys/container-closure-system-descrplasticbagsdt.pdf 334.1 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s6-cont-closure-sys/container-closure-system-descrplasticbagsdt.pdf 334.1 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s2-manuf/manuf-process-and-controls-detoxificationandultrafiltnt.pdf 332.9 kB
0114_2/m1/eu/12-form/common/common-form-annex-qpdeclaration.pdf 329.0 kB
0114_2/m1/eu/14-expert/141-quality/quality-signature-ericjohnson.pdf 328.7 kB
0114_2/m2/23-qos/appendices-flowchartfacilities.pdf 321.8 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s7-stab/postapproval-stability-d.pdf 320.9 kB
0114_2/m3/32-body-data/32p-drug-prod/pre-filled-syringe/32p3-manuf/process-validation-asepticvalidationdtcc.pdf 320.2 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s7-stab/postapproval-stability-t.pdf 319.7 kB
0114_2/m1/eu/12-form/common/common-form-annex-1-scopebackground.pdf 312.8 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s4-contr-drug-sub/32s44-batch-analys/batch-analyses-d.pdf 307.4 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s4-contr-drug-sub/32s44-batch-analys/batch-analyses-t.pdf 303.6 kB
0114_2/m2/23-qos/drug-substance-containerclosuresystemd.pdf 301.7 kB
0114_2/m2/23-qos/drug-substance-containerclosuresystemt.pdf 301.7 kB
0114_2/m1/eu/12-form/it/it-form-annex-proofofpayment.pdf 299.4 kB
0114_2/m1/eu/10-cover/es/es-cover.pdf 293.3 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s2-manuf/control-of-materials-materialsolutiond.pdf 290.1 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s2-manuf/manuf-process-and-controls-batchnumberingt.pdf 287.0 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s2-manuf/manuf-process-and-controls-batchnumberingd.pdf 286.8 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s7-stab/stability-data-trendanalysisdt.pdf 285.1 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s7-stab/stability-data-trendanalysisdt.pdf 285.1 kB
0114_2/m1/eu/12-form/cz/cz-form-annex-proofofpayment.pdf 274.5 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s4-contr-drug-sub/32s41-spec/specification-d.pdf 271.1 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s4-contr-drug-sub/32s41-spec/specification-t.pdf 270.0 kB
0114_2/m3/32-body-data/32p-drug-prod/pre-filled-syringe/32p2-pharm-dev/pharmaceutical-development-dtcc.pdf 265.1 kB
0114_2/m2/23-qos/drug-product-pharmaceuticaldevelopmentdtcc.pdf 265.0 kB
0114_2/m1/eu/12-form/be/be-form-annex-proofofpayment.pdf 259.2 kB
0114_2/m1/eu/12-form/ie/ie-form-annex-proofofpayment.pdf 249.8 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s6-cont-closure-sys/container-closure-system-extract50plasticbagsdt.pdf 234.4 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s6-cont-closure-sys/container-closure-system-extract50plasticbagsdt.pdf 234.4 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s5-ref-stand/reference-standards-t.pdf 234.1 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s5-ref-stand/reference-standards-d.pdf 233.0 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s2-manuf/control-critical-steps-overviewd.pdf 228.5 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s2-manuf/control-critical-steps-overviewt.pdf 227.3 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s6-cont-closure-sys/container-closure-system-overviewplasticbagsdt.pdf 225.7 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s6-cont-closure-sys/container-closure-system-overviewplasticbagsdt.pdf 225.7 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s2-manuf/manufacturer-d.pdf 217.4 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s2-manuf/manufacturer-t.pdf 216.5 kB
0114_2/m3/32-body-data/32p-drug-prod/pre-filled-syringe/32p3-manuf/manufacturers-dtcc.pdf 214.2 kB
0114_2/m2/23-qos/drug-product-containerclosuresystemdtcchyclone.pdf 213.0 kB
0114_2/m1/eu/additional-data/pl/pl-additionaldata-stampdutyforpoa.pdf 171.0 kB
0114_2/m2/23-qos/drug-substance-referencestandardsormaterialsd.pdf 151.5 kB
0114_2/m2/23-qos/drug-substance-referencestandardsormaterialst.pdf 151.2 kB
0114_2/m1/eu/12-form/common/common-form-annex-gmpcertificategsksae.pdf 150.9 kB
0114_2/m3/32-body-data/32s-drug-sub/tt-marburg/32s7-stab/postapproval-stability-monitoringcommercialbatchest.pdf 145.8 kB
0114_2/m3/32-body-data/32s-drug-sub/d-marburg/32s7-stab/postapproval-stability-monitoringcommercialbatchesd.pdf 145.5 kB
0114_2/m1/eu/12-form/common/common-form-annex-annexa.pdf 139.0 kB
0114_2/m1/eu/12-form/pl/pl-form-annex-proofpayment.pdf 138.5 kB
0114_2/m1/eu/10-cover/common/common-cover-annex-emaadvice.pdf 135.5 kB
0114_2/m1/eu/12-form/lt/lt-form-annex-proofofpayment.pdf 131.7 kB
0114_2/m1/eu/12-form/common/common-form-annex-manufauthorisationgsksae.pdf 126.9 kB
0114_2-workingdocuments/eCTDReport.html 126.3 kB
0114_2/m1/eu/additional-data/ro/ro-additionaldata-letterofintent.pdf 98.5 kB
0114_2/m1/eu/14-expert/141-quality/quality-cv-ericjohnson.pdf 78.9 kB
0114_2/m1/eu/12-form/pl/pl-form-annex-establishmentloc.pdf 74.7 kB
0114_2-workingdocuments/Validation-checklist-type-ii-quality-variations_en.docx 58.8 kB
0114_2/m1/eu/12-form/ro/ro-form-annex-proofpayment.pdf 52.1 kB
0114_2/m1/eu/12-form/bg/bg-form-annex-proofofpayment.pdf 50.4 kB
0114_2/m1/eu/12-form/hu/hu-form-annex-proofofpayment.pdf 50.2 kB
0114_2/m1/eu/12-form/sk/sk-form-annex-proofpayment.pdf 49.1 kB
0114_2/index.xml 45.3 kB
0114_2/m1/eu/eu-regional.xml 43.5 kB
0114_2/m1/eu/12-form/es/es-form-annex-proofofpayment.pdf 39.1 kB
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0114_2/util/style/ectd-2-0.xsl 2.0 kB
0114_2/index-md5.txt 32 Bytes

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